[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR529.1115]

[Page 328]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  529.1115  Halothane.

    (a) Specifications. The drug is a colorless, odorless, nonflammable, 
nonexplosive, heavy liquid containing 0.01 percent thymol as a 
preservative.
    (b) Sponsor. See 000856 and 012164 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use--(1) Amount. Two to 5 percent of inhaled 
atmosphere for induction of anesthesia; 0.5 to 2 percent for maintenance 
of anesthesia.\1\
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    \1\ These conditions have been reviewed by FDA and found effective. 
NADA's for similar products for these conditions of use need not include 
effectiveness data as specified by Sec.  514.111 of this chapter, but 
may require bioequivalency and safety information.
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    (2) Indications for use. For nonfood animals for the induction and 
maintenance of anesthesia.\1\
    (3) Limitations. Administered by inhalation. May be administered 
with either oxygen or a mixture of oxygen and nitrous oxide. Place drug 
vaporizer between the gas supply and breathing bag to prevent 
overdosage. Not recommended for obstetrical anesthesia except when 
uterine relaxation is required. Do not use in pregnant animals; 
information on possible adverse effects on fetal development is not 
available. Operating rooms should have adequate ventilation to prevent 
accumulation of anesthetic gases. Not for use in animals intended for 
food. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.\1\

[46 FR 27915, May 22, 1981, as amended at 62 FR 29014, May 29, 1997]